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NIH, Warp Speed streamline preventive mAb, vaccine testing via clinical trial network

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On the back of its first COVID-19 mAb investment, Operation Warp Speed launched a clinical trial network with NIH on Wednesday to streamline testing of the modality in prophylactic settings.

The COVID-19 Prevention Trials Network (COVPN), which will also facilitate Phase III testing of vaccines, was established by NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and is a “functional unit” of Operation Warp Speed.

COVPN totals more than 100 trial sites in and outside the U.S. across four existing networks: the HIV Vaccine Trials Network (HVTN); the HIV Prevention Trials Network (HPTN); the Infectious Diseases Clinical Research Consortium (IDCRC); and the AIDS Clinical Trials Group.

Vaccine testing will be led by Fred Hutchinson Cancer Research Center researcher Larry Corey, and Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland, while the network’s mAb testing will be helmed by Myron Cohen, director of the Institute for Global Health & Infectious Diseases at the University of North Carolina, and David Stephens, who chairs the Department of Medicine at Emory University.

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), which closed a $450 million deal with Operation Warp Speed on Tuesday covering thousands of doses of REGN-COV2, told BioCentury its prevention study will use COVPN sites, while its treatment studies will not (see “Operation Warp Speed Secures Thousands of Antibody Doses”).

The company partnered with NIAID on Monday to launch a Phase III trial of the mAb cocktail as post-exposure prophylaxis.

Vaccine harmonization

COVPN will use a harmonized vaccine protocol developed by the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) to facilitate data comparisons.

“Starting this summer, this new network will leverage existing infrastructure and engage communities to secure the thousands of volunteers needed for late-stage clinical trials of promising vaccines,” HHS Secretary Alex Azar said in a statement.

Among vaccine developers, Moderna is the only one so far to disclose plans to conduct Phase III testing in the NIH network.

Slated to begin in July, the primary endpoint of its Phase III study of mRNA-1273 will be prevention of symptomatic COVID-19 disease. Secondary endpoints include prevention of severe COVID-19 disease, as defined by the need for hospitalization, and prevention of infection by SARS-CoV-2 (see “Moderna Vaccine Phase III will be Conducted in Trial Network”).

There are at least six other groups developing COVID-19 vaccines that are affiliated with Operation Warp Speed, and National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci noted on Monday that at least four vaccines are slated to begin harmonized late-stage trials between July and October.

Johnson & Johnson (NYSE:JNJ) declined to comment, and the other developers did not respond to inquiries regarding whether they will test their vaccines with COVPN.

AstraZeneca plc (LSE:AZN; NYSE:AZN), which licensed AZD1222 from the University of Oxford, is the most advanced, already enrolling volunteers in a Phase II/III trial in the U.K. In May, Warp Speed awarded AZ up to $1.2 billion to support the development and manufacturing of the recombinant adenovirus vector (see “Operation Warp Speed Takes First Step”).

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) plan to start enrolling volunteers in a Phase III trial this month for their RNA vaccine BNT162, and Inovio Pharmaceuticals Inc. (NASDAQ:INO) expects a summer start for a Phase II/III study of DNA vaccine INO-4800 (see “Vaccine Guidance Hits Mark”).

Next up is Novavax Inc. (NASDAQ:NVAX), which plans to start a Phase III trial in the fall. The biotech closed a $1.6 billion deal with Warp Speed on Tuesday to supply 100 million doses of NVX-CoV2373, a recombinant nanoparticle vaccine (see “Novavax Gets Another Boost”).

Two Warp Speed finalists have preclinical vaccine candidates.

J&J plans to begin this month a Phase I/IIa trial of Ad26.COV2-S, an adenoviral vector vaccine.

Merck & Co. Inc. (NYSE:MRK) is developing two vaccines, and plans to start clinical testing of both this year. The pharma is partnered with non-profit IAVI to develop a recombinant vesicular stomatitis virus-based vaccine. HHS’s Biomedical Advanced Research and Development Authority (BARDA) is providing $38 million in early development funding.

Merck also acquired European vaccine company Themis Bioscience GmbH and is developing its live attenuated COVID-19 vaccine (see “Merck Takes a Page from its Ebola Strategy”).

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